The U.S. Chamber of Commerce’s (Global Intellectual Property Center) submission (7 February 2014, USTR-2013-0040) to USTR’s 2014 Special 301 expressed the following concerns with South Africa’s draft National Policy on Intellectual Property. The Chamber’s concerns include proposed changes in patentability guidelines and the possible introduction of a robust compulsory licensing framework. The Chamber requested USTR to push South Africa to adopt a “modern term of protection for copyright” (life plus 70).
South Africa
Patents
Patentability
Proposal are currently being considered in South Africa that state that developing countries can adopt IP policies that limit the extent of patenting and facilitate the introduction of generic competition. Further, the pharmaceutical patentability requirements included in the draft policy closely resemble that of Section 3(d) of India’s Patent Act, which continues to be concerning to industry. The Chamber finds troublesome any IP policies which mirror India’s due to the rapid deterioration in India’s IP environment over the last two years. The Chamber believes that policies that deter incremental innovation will damage both the IP environment and the South African economy as incremental innovation provides incentives for companies to invest in a given country and bring new products to market. We urge the U.S. Government to work with the South African Government to reconsider the existing clauses in the Draft Policy, which would restrict, if not eliminate, forms of incremental innovation.
Compulsory Licensing
South Africa is also considering introducing a “public health perspective into national IP laws” that would include the South African Government implementing a broad compulsory licensing policy. The Chamber believes the introduction of a compulsory licensing policy would not only represent a significant deterioration in the South Africa’s IP system but also deter investment in the South African market. We strongly encourage the South African government to remove the references to compulsory licensing from current proposals in order to both make South Africa an attractive destination for foreign investment and ensure the government’s national IP policy will create a robust system of IP protections.
Data Protection
Current recommendations call for the South African Government to comply with Article 39 of TRIPS in terms of data protection. It is the Chamber’s understanding that the Government does not intend to withhold the disclosure of information from clinical trials in order to benefit generic companies. However, governments usually allow for the protection of data by providing an exclusivity period, which allows for follow-on products to rely on the data after the exclusivity period lapses. The Chamber encourages the U.S. Government to work with their South African counterparts to ensure that data exclusivity is included in the national IP policy moving forward.
Patent Extension
The Draft Policy acknowledges that the South African government is “under pressure to amend the Patents Act to allow for patent extension or restoration to compensate for time lost due to regulatory delays” at the Medical Controls Council (MCC), but does not make direct recommendation to introduce such a policy. We encourage the South African Government to introduce patent term extension in order to make up for time lost during regulatory approval process and allow for the innovator to recover their research and development investment in the creation of a product.
Copyright
Term of Protection
The Draft Policy does not make any changes to existing South African law, which only provides for a copyright term of the life of the author plus 50 years. As both developed and developing countries alike are recognizing the importance of extending the copyright term to 70 years, the Chamber recommends that the U.S. Government work with the South African Government to ensure that the final national IP policy includes the modern term of protection for copyright.